NCT04990947Unknown不适用
Direct Measurement of Food Intake Behaviour in Obese Women Before and After Bariatric Surgery or Lifestyle Intervention
Rijnstate Hospital1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年4月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Changes in caloric intake
研究概览
简要总结
To assess changes in food intake and food preference (e.g., fat and sugar) after bariatric surgery and lifestyle intervention alone with a direct measurement.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 67 years of age (standard for eligibility for bariatric surgery)
- •Patients must be able to adhere to the study visit schedule
- •Independently mobile
- •Patients must be able to give informed consent (IC) prior to any study procedures
- •Surgical (1) and non-surgical (2) groups:
- •Eligible for bariatric surgery (BMI > 35 kg/m2 and clinically indicated bariatric surgery operation in agreement with the IFSO criteria)
- •Patients with a BMI of 30-40 kg/m2, who are planning to join the COOL-lifestyle program
排除标准
- •Pre-operatively/lifestyle group: Factors impairing ability to consume meal such as: Significant dysphagia; Gastric outlet obstruction; Anything factor that prevents subjects from drinking or eating a meal
- •Post-operatively: Factors impairing ability to consume meal such as: Significant and persistent surgical complications or anything that prevents subjects from drinking or eating a meal.
- •Systemic or gastrointestinal condition which may affect food intake or preference (including diabetes mellitus)
- •Pregnancy or lactation, or planning to get pregnant during the study period
- •Patients who have an intolerance or allergy for one of the components of the test product (e.g. lactose)
- •Active and significant psychiatric illness including substance misuse
- •Significant cognitive or communication issues
- •Medications with documented effect on food intake or food preference
- •Participating in another scientific study at the same time, if
结局指标
主要结局
Changes in caloric intake
时间窗: Before RYGB / lifestyle compared to 4 weeks, 3 months, 6 months and 12 months after RYGB / lifestyle
kcal consumed
次要结局
- Weight / BMI(baseline, 4weeks, 3 months, 6 months, 12 months)
- Drinking microstructure over time(baseline, 4weeks, 3 months, 6 months, 12 months)
- Change in self-reported hunger, thirst, fullness, preference(baseline, 4weeks, 3 months, 6 months, 12 months)
研究者
研究点 (1)
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